Evidence map›Paper›PMID 32434935›Full record

Observational studyBMJ open2020

Dabigatran initiation in patients with non-valvular AF and first acute ischaemic stroke: a retrospective observational study from the SITS registry.

Irene Escudero-Martinez, Michael Mazya, Christine Teutsch, Norbert Lesko, Zuzana Gdovinova, Leonardo Barbarini, Waldemar Fryze, Michal Karlinski, Adam Kobayashi, Georgi Krastev and 8 more

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03258645 (Pradaxa Initiation Post-Stroke Study), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.9field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03258645 completednot on this map

Pradaxa Initiation Post-Stroke Study: SITS-Pradaxa 1. A Retrospective Analysis From the SITS-AF Registry on Treatment Initiation of Dabigatran Etexilate in Non-valvular Atrial Fibrillation Patients Hospitalized With Acute Ischemic Stroke

TypeobservationalSponsorBoehringer IngelheimRan2018 to 2019Enrolled1,489ConditionsAtrial FibrillationArmsDabigatran
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2021
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 14 institutions in 9 countries.

Irene Escudero-MartinezDepartment of Neurology, Hospital Universitario Virgen del Rocio and Instituto de Biomedicina de Sevilla, Seville, Spain.ORCID 0000-0003-1838-0235
Michael MazyaDepartment of Neurology and Department of Clinical Neuroscience, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.
Christine TeutschMedical Department, TA Cardiometabolism and Metabolics, Boehringer Ingelheim International GmbH, Ingelheim, Germany.
Norbert LeskoDepartment of Neurology, Faculty of Medicine, Pavol Jozef Šafárik University in Košice, Košice, Slovakia.
Zuzana GdovinovaDepartment of Neurology, Faculty of Medicine, Pavol Jozef Šafárik University in Košice, Košice, Slovakia.
Leonardo BarbariniDepartment of Neurology, Ospedale Vito Fazzi, Lecce, Italy.
Waldemar FryzeOddział Kliniczny Neurologii, Copernicus PL, M. Kopernika Hospital, Gdańsk, Poland.
Michal KarlinskiSecond Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland.
Adam KobayashiFaculty of Health Sciences and Physical Education, Kazimierz Pulaski University of Technology and Humanities, Radom, Poland.
Georgi KrastevDepartment of Neurology, Faculty Hospital Trnava, Trnava, Slovakia.
Ana Paiva NunesStroke Unit, Centro Hospitalar Lisboa Central, Lisbon, Portugal.
Katarina PasztoovaDepartment of Neurology, General Hospital, Komárno, Slovakia.
André PeetersDepartment of Neurology, Cliniques Universitaires St-Luc, Brussels, Belgium.
Piotr SobolewskiThe Faculty of Medicine and Health Sciences, Jan Kochanowski University, Kielce, and Department of Neurology and Stroke Unit, Holy Spirit Specialist Hospital, Sandomierz, Poland.
Aleksandras VilionskisClinic of Neurology and Neurosurgery, Institute of Clinical Medicine, Vilnius University, Stroke Center, Republican Vilnius University Hospital, Vilnius, Lithuania.
Danilo ToniDepartment of Human Neurosciences, Sapienza University of Rome, Rome, Italy.
Niaz AhmedDepartment of Neurology and Department of Clinical Neuroscience, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden niaz.ahmed@sll.se.
SITS Investigators
Karolinska University Hospital · SEUniversity of Pavol Jozef Šafárik · SKBoehringer Ingelheim (Germany) · DECliniques Universitaires Saint-Luc · BEInstitute of Psychiatry and Neurology · PLInstituto de Biomedicina de Sevilla · ESJan Kochanowski University · PLJ. Selye University · SKKazimierz Pułaski University of Technology and Humanities in Radom · PLOspedale Vito Fazzi · ITSapienza University of Rome · ITUnidade Local de Saúde de São José · PTUniversity of Trnava · SKVilnius University · LT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe optimal timing for initiation of dabigatran after acute ischaemic stroke (AIS) is not established. We aimed to evaluate initiation timing and clinical outcomes of dabigatran in AIS patients with non-valvular atrial fibrillation (NVAF).

designRetrospective study based on prospectively collected data in SITS (Safe Implementation of Treatment in Stroke) Thrombolysis and Thrombectomy Registry from July 2014 to July 2018.

participantsEuropean NVAF patients (≥18 years) hospitalised after first-ever ischaemic stroke.

settingA multinational, observational monitoring register.

interventionDabigatran initiation within 3 months after the ischaemic stroke. PRIMARY AND SECONDARY OUTCOMES: The primary outcome was time from first-ever ischaemic stroke (index event) to dabigatran initiation. Additional outcomes included physicians' reasons for delaying dabigatran initiation beyond acute hospital discharge and outcomes within 3 months of index event.

methodsWe identified patients with NVAF who received dabigatran within 3 months of the index event. We performed descriptive statistics for baseline and demographic data and clinical outcomes after dabigatran initiation.

resultsIn total, 1489 patients with NVAF received dabigatran after AIS treated with thrombolysis and/or thrombectomy. Of these, 1240 had available initiation time. At baseline, median age was 75 years; 53% of patients were women, 15% were receiving an oral anticoagulant, 29% acetylsalicylic acid and 4% clopidogrel. Most patients (82%) initiated dabigatran within 14 days after the index event. Patients initiating earlier had lower stroke severity from median NIHSS 8 (IQR 6-13) if initiated within 7 days to NIHSS 15 (9-19) if initiated between 28 days and 3 months. Most common reasons for delaying initiation were haemorrhagic transformation or intracranial haemorrhage, stroke severity and infarct size. Few thrombotic/haemorrhagic events occurred within 3 months after the index event (20 of 926 patients, 2.2% with the available data).

conclusionsOur findings, together with previous observational studies, indicate that dabigatran initiated within the first days after an AIS is safe in patients treated with intravenous thrombolysis, endovascular thrombectomy or both. TRIAL REGISTRATION NUMBER: SITS Thrombolysis and Thrombectomy Registry (NCT03258645).

Indexed as

Atrial FibrillationBrain IschemiaIschemic StrokeStrokeAgedAnticoagulantsDabigatranFemaleHumansMaleRegistriesRetrospective StudiesAnticoagulantsDabigatranadult cardiologyanticoagulationstroke

Identifiers

PMID32434935
PMCPMC7247395
OpenAlexW3027064464

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.